A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon

NCT04826705 | Active Not Recruiting

• 1 other identifier: the PROMISING Study
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 9

Brief Summary

There have been a number of randomized controlled studies (RCT) showing the efficacy of the endovascular treatment with drug-coated balloons (DCB) in the femoropopliteal artery lesions. However, these studies have been carefully designed, and most of them have excluded long-length lesions and severely calcified lesions. In addition to being used alone in the real word, drug-coated balloons (DCB) are also used in combination with stents or debulking devices, but in these randomized controlled studies (RCT) they are only compared with standard percutaneous transluminal angioplasty (PTA). Therefore, the investigators initiated this study, which is a prospective, multicenter, observational real-world study of short and long-term outcome in endovascular treatment of femoropopliteal arterial occlusive lesions with DCB.

Conditions

Drug-coated Balloon; Femoropopliteal Artery Occlusion; Angioplasty

Outcome Measures

Primary Outcomes (2)

• Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional

  Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or \>0.15 when compared to post-procedure baseline.

  48 months

• Major adverse events

  Operation-related acute thrombosis, arterial embolism, major amputation and all-cause mortality.

  48 months

Secondary Outcomes (6)

• Changes of the patency rate of target lesions at post-interventional

  1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months

• Technical success rate

  1 week

• Vascular quality of life questionnaire(VascuQol)

  1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months

• The patient's ulcer healing

  1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months

• Freedom from clinically-driven target lesion revascularization(CD-TLR) rate at post-interventional

  1 month, 3 months, 6 months, 12 months, 24 months, 36 months

Interventions

Drug-coated Balloon DEVICE

To observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with femoralpopliteal artery occlusion.

You may qualify if:

• Rutherford grade 2-5.
• Femoral popliteal artery stenosis or occlusion, a clear outflow tract no less than 10cm long at the distal end of the knee should be continuous with a clear outflow tract under the ankle.
• Patients who understand the purpose of this study, volunteer to participate in the experiment, sign informed consent and are willing to follow up.
• The guide wire needs to pass through the lesion.
• Life expectancy\> 24 months.
• Patients with thrombosis of the lower extremities, patients who received drug-coated balloon (DCB) intervention after thrombus removal through mechanical thrombus removal, percutaneous catheter thrombolysis, and thrombus removal.
• Patients who have received DCB intervention for both lower limbs can be enrolled in the group according to the intracavitary treatment time.
• There is at least one continuous infrapopliteal outflow artery or obtained through intravascular reconstruction.
• For combined aortic iliac artery disease, the blood flow can be recanalized after intravascular reconstruction without residual stenosis exceeding 50%.

You may not qualify if:

• Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage or myocardial infarction within 3 months before enrollment.
• Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
• Patients who have participated in clinical trials of drugs or other medical devices that interfere with this clinical trial within the past 3 months.
• Pregnant and lactating women.
• Patients who are unable or unwilling to participate in this trial.
• Patients with Berg's disease.
• Patients who have undergone arterial bypass on the treatment side.

Sponsors & Collaborators

• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology: lead
• RenJi Hospital: collaborator
• Zhejiang University: collaborator
• Xuanwu Hospital, Beijing: collaborator
• First People's Hospital of Hangzhou: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• Qingdao University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator

Study Sites (9)

Zibo Feng

Wuhan, Hubei, 430000, China

Location

Xuanwu Hospital Capital Medical University

Beijing, China

Location

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, China

Location

Hangzhou First People's hospital of Medical College of Zhejiang University

Hangzhou, China

Location

the First Affiliated hospital of Medicine College of Zhejiang University

Hangzhou, China

Location

Qingdao Haici hospital affiliated to Qingdao University

Qingdao, China

Location

Renji Hospital of Shanghai Jiaotong University

Shanghai, China

Location

Zhongshan Hospital of Fudan University

Shanghai, China

Location

the second Affiliated Hospital of Medical College of Suzhou University

Suzhou, China

Location

Study Officials

• Zibo Feng

  Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vascular Surgery, Liyuan Hospital

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 5, 2024

Record last verified: 2023-12

Locations

CN (9)